Data synchronization between two or more analyte detecting devices in a database

ABSTRACT

An analyte measurement system includes one or more handheld analyte meters and/or measurement devices and a means for collecting data, preserving data integrity, and uniquely identifying patient data received from multiple sources. For example, provided herein is a means to uniquely identify patients and their data when the data is collected from one or more measurement devices. By providing a way to allow the patients to use multiple sources to collect data, the system described herein provides patients with more flexibility, which should encourage better compliance to protocols. Further, by having a way to uniquely identify patients&#39; data without requiring a patient to only use one analyte meter, for example, data can be centralized and analysis can be done with more assurance that all of the patient&#39;s data is being considered in the analyses.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/684,456, filed Aug. 23, 2017, which is a continuation of U.S.application Ser. No. 13/984,809, filed Nov. 20, 2013, now U.S. Pat. No.9,760,679, which is a national phase application of PCT Application No.PCT/US11/66422, filed Dec. 21, 2011, which claims the benefit of U.S.Provisional Application No. 61/442,063, filed Feb. 11, 2011, all ofwhich are incorporated by reference herein in their entireties and forall purposes.

This application is related to U.S. Provisional Patent Application No.61/442,085 filed on Feb. 11, 2011; U.S. Provisional Application No.61/486,117 filed on May 13, 2011; U.S. Provisional Patent ApplicationNo. 61/442,092 filed on Feb. 11, 2011; U.S. Provisional Application No.61/485,840 filed on May 13, 2011; U.S. Provisional Application No.61/442,093 filed on Feb. 11, 2011, and U.S. Provisional Application No.61/442,097 filed on Feb. 11, 2011, all of which are incorporated byreference herein in their entireties and for all purposes.

BACKGROUND OF THE INVENTION The Field of the Invention

The present invention relates to analyte measurement systems. Morespecifically, the present invention relates to a means for preservingdata integrity and uniquely identifying patient data received frommultiple sources.

Background

One tool used in diabetes management is an analyte meter. An analytemeter is typically used to measure the blood glucose level of a userbased on a sample of blood. The process of using an analyte meter is notcomplicated, and is often performed several times a day. First, the userinserts an analyte test strip into a test strip port of the meter. Theuser then lances her finger to obtain a small sample of blood. The bloodsample is then placed onto the analyte test strip, and the meteranalyzes the blood sample. The meter then typically displays a bloodglucose level from the analysis.

In today's budget conscious health care world there is intense pressureto deliver improved outcomes in cost conscious ways. One way toaccomplish this goal in the realm of diabetes care is to moreeffectively use blood glucose (BG) data and other biometric datacollected from patients to make effective therapy and lifestylesuggestions. To effectively collect and analyze data, the patient mustcomply with prescribed BG (or other biometric) testing protocols. Thereis also a need for providing a means for easily collecting andcommunicating data.

What is needed is a means for collecting data, preserving dataintegrity, and uniquely identifying patient data received from multiplesources.

BRIEF SUMMARY

Presented herein is an analyte measurement system. The analytemeasurement system includes one or more handheld analyte meters and/ormeasurement devices and a means for collecting data, preserving dataintegrity, and uniquely identifying patient data received from multiplesources. For example, provided herein is a means to uniquely identifypatients and their data when the data is collected from one or moremeasurement devices. By providing a way to allow the patients to usemultiple sources to collect data, the system described herein providespatients with more flexibility, which should encourage better complianceto protocols. Further, by having a way to uniquely identify patients'data without requiring a patient to only use one analyte meter, forexample, data can be centralized and analysis can be done with moreassurance that all of the patient's data is being considered in theanalyses.

In addition, the methods discussed herein consider ease-of-use. Byproviding easy to use systems, patients are more likely to comply withtesting protocols.

Finally, these methods also keep in mind data integrity. When multiplemeters are used, the likelihood of a meter being lost or stolenincreases. The systems proposed allow patients to maintain multiplemeters without excessive risk to patient privacy as it relates tomedical data (i.e.; HIPAA requirements). The methods guarantee that thedata coming from any particular meter is from the patient the meter wasassigned to, and therefore protects the patient's privacy.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings, which are incorporated herein, form part ofthe specification. Together with this written description, the drawingsfurther serve to explain the principles of, and to enable a personskilled in the relevant art(s), to make and use the present invention.

FIG. 1 provides a front-side view of handheld analyte measurement devicein accordance with one embodiment presented herein.

FIG. 2 is a flowchart illustrating one embodiment presented herein.

FIG. 3 is a continuation of the flowchart from FIG. 2.

FIG. 4 is a flowchart illustrating another embodiment presented herein.

DETAILED DESCRIPTION OF THE INVENTION

Before the embodiments of the present invention are described, it is tobe understood that this invention is not limited to particularembodiments described, and as such may, of course, vary. It is also tobe understood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting, since the scope of the embodiments of the invention will belimited only by the appended claims.

FIG. 1 provides a front-side view of handheld analyte measurementdevice, such as an analyte meter 102, in accordance with one embodimentpresented herein. In one embodiment, analyte meter 102 includes a teststrip port 104, a display unit 106, and at least one control button 108.In practice, an analyte test strip (or sensor) is inserted into teststrip port 104 in order to conduct an analyte test; for example, a bloodglucose reading or a blood ketone reading. Meter 102 includes software(as described below) to analyze the sample placed on the test strip, andthe results of the analysis are typically displayed to the user viadisplay unit 106. The user may also use control button 108 to provideappropriate instructions to meter 102.

In one embodiment, meter 102 includes one or more diabetes managementsoftware applications. The integration of software applications withmeter 102 provides an opportunity to augment traditional glucose and/orketone readings to provide more useful information and feedback topatients and doctors. As such, meter 102, with loaded softwareapplications, can be part of a robust therapy management system. Thesoftware applications can be factory pre-loaded, or installed by theuser or health care provider after first use by the user.

Analyte meter 102 may further include one or more internal or externalcommunication modules. The communication module(s) may be used toreceive and/or transmit data and/or program instructions. Thecommunication module(s) may also download software applications from oneor more servers. In one embodiment, the communication module is used tocommunicate with one or more external devices; such as, for example, acentral server or central database, a medication (drug) deliver device;a cellular phone; a laptop computer; a mobile device, such as a PDA,iPhone, iPad, tablet computer, etc.; a desktop computer; an analytemeter; and/or another analyte measurement system. In one embodiment, thecommunication module can be configured for wireless communication to anexternal device. Wireless communication may be provided by, for example,but not limited to, radio frequency (RF) communication (e.g.,Radio-Frequency Identification (RFID), Zigbee communication protocols,WiFi, infrared, wireless Universal Serial Bus (USB), Ultra Wide Band(UWB), Bluetooth® communication protocols, and cellular communication,such as code division multiple access (CDMA) or Global System for Mobilecommunications (GSM).

The methods described in this disclosure depend on the collection ofidentifying information by a central database, server(s), or “cloud.”For the scenarios provided below, the following are assumed: 1) acentralized server or database exists that can be accessed by the userthrough multiple conduits (e.g., a web-based database accessible fromany internet enabled PC, cell phone, tablet PC, etc.); 2) the analytemeter contains a unique identifier (e.g., serial number); and 3) theconduits used to upload data from the analyte meter to the centraldatabase are uniquely identifiable (e.g., via a MAC address or callingphone number). The following scenarios are considered below: 1) thepatient has multiple analyte meters in multiple locations (e.g., athome, office, gym, etc.); 2) the patient's BG readings are sometimestaken at a hospital or clinic, where there is sanctioned use of themeters by multiple patients; 3) the patient is given multiple metersthat are re-used by the clinic, to take home; 4) multiple patients sharea single meter (e.g., a husband borrows wife's meter); and 5) a meter islost or stolen and an attempt to use the meter is made by anunauthorized user.

As used herein, the term “device” is intended to include multipleanalyte meters (either discreet or continuous blood glucose meters),wired- or wireless-equipped biometric measurement devices (e.g., bloodpressure measurement devices), or any other medical devices. In somecases, the device may act as a data hub such that it contains not justglucose measurement data, but also other biometric data (e.g., bloodpressure data, weight, pulse rate, etc.) that has been manually orautomatically entered into the device or communicated to the device. Themethods described herein provides a way to uniquely identify the patientregardless of which device is used and to associate the uploaded datawith that patient. The following section describes the various ways inwhich this unique identification can be done.

1) Barcode, RFID, or Fingerprint Method.

In one embodiment, the device may include a fingerprint reader toidentify the patient. In another embodiment, the device may include abarcode or other optical reader that identifies the patient via ahandheld identifier tag. In another embodiment, the device may includean RFID reader that identifies the patient via a RF card/tag kept by thepatient. Identifiers or RF cards/tags may be made small enough to fit ona key chain, in a wallet, or in a carrying case that contains thepatient's device, lancets, and/or test strips. In one embodiment, thepatient is not allowed to take an analyte reading without first makingcontact (physical or electrical) between the device and identifier (ortaking a fingerprint reading). The identifier used at the time of theanalyte reading may be attached to each said reading. Thus each readinguniquely identifies itself to the patient. As long as the patient onlyuses devices that require the identifier, all of their data will beuniquely identifiable and can be aggregated to a central location.Devices may be programmed to accept only one single identifier (orfingerprint), to enforce no sharing of the device, or multipleidentifiers to allow sanctioned re-use of devices. In the case whereonly a single identifier is allowed, the device will have to be pairedwith the identifier on first use.

2) Association of Devices and Conduit Devices with a Patient.

The first time a patient uploads data, either directly to a PC orcellphone, or to the internet via a PC or cellphone conduit, theidentifiers (MAC addresses, serial numbers, etc.) of the device and dataconduit are collected. At the time a patient is registered, a PatientRecord is established in the database system and the Patient Recordincludes “Secondary ID information” (that may be used to confirm apatient's identity without communicating their full name). ThisSecondary ID Information includes information such as SSN, DOB, zipcode, mother's maiden name, etc. A patient may also be assigned a uniqueidentifier (and optionally a password) at the time of registration. Thenext time the aggregating database sees the same analyte device orconduit it may assume that it is the same patient “returning” with moredata (or may provide a verification prompt). When the aggregating systemdoes not recognize the device and/or conduit devices, it can ask if thepatient is a returning patient (or simply ask the patient to identifythemselves using Secondary Information (to minimize patient privacyissues). If the patient is a returning patient, they could be asked fortheir unique ID and password, and/or other Secondary ID Information oridentifiers to confirm their identity. An unrecognized patient wouldhave to be registered in the system before they could access the system.Once the patient identity has been confirmed, the new device and/or dataconduit identifiers can be added to their record. This scenario isillustrated in the flowchart in FIGS. 2 and 3.

Another aspect of this invention is that a unique patient ID, generatedby the central database, can be stored in the device software and incommunication software in the conduit as part of the registrationprocess—this communication software can be loaded into the conduit bythe device the first time it is attached or loaded from the web or othercommunication network at an address specified by the device. This waythe unique patient ID format can be controlled by the central databaseand uniqueness can be guaranteed. When the data is uploaded, the uniquepatient ID is included twice in the upload stream, by the devicesoftware and by software in the conduit (communication driver), andextracted by the central database for data association. When the uniquepatient ID from the device is not recognized, or that from the conduitare not recognized, the new device or conduit proceeds to a registrationprotocol, as described above. Other means to perform this function canbe contemplated, such as having the conduit software check the devicefor matching patient IDs and sending a flag to the central database ifthey do not match.

For multiple patients using the same conduit, the communication driverwould need to maintain multiple unique patient IDs and some additionalpatient information (such as first name), including security informationsuch as a password, to deal with the situation where new devices areintroduced. When a new device is detected and multiple unique patientIDs are stored in the communication driver, it would need to request theuser to select from the list patient information associated with thestored unique patient IDs.

Process flows are provided below—these are in terms of a device attachedvia wire to a PC connected to the internet; however, the general methodis similar for other connection methods such as 3G cellular connection,or pager network based communication.

An example registration process flow is as follows: a) register uniquepatient ID on website—patient provides additional security information;b) Connect new device to new PC—device installs communication driver onPC (communication driver has instructions to upload data from device toweb address automatically when device is attached); and c) uponcompletion of the registration process, website downloads unique patientID to device and communication driver.

An example upload process flow is as follows: a) attach device to PC,upload begins automatically as driven by communication driver; b) deviceand communication driver both place unique patient ID in data stream;and c) central database recognizes and matches both unique patient IDsand stores data associated with this ID.

An example upload process flow where a new device is introduced is asfollows: a) attach new device to PC with existing communication driver;b) device places a null character in the unique patient ID field of thedata stream; c) the communication driver detects the mismatch of theunique patient ID with any of its stored IDs and requests the user toidentify the unique patient ID based on associated patient informationand/or security information; d) upon proper confirmation, thecommunication driver downloads the unique patient ID to the new deviceand includes the unique patient ID in the device field of the datastream sent to the central database; and e) central database recognizesand matches both unique patient IDs and stores data associated with thisID. For configurations where the upload conduit may not have a userinterface, the security confirmation could be provided through thedevice UI.

An example upload process flow where a new PC is introduced is asfollows: a) attach device to a new PC—device installs communicationdriver on PC (communication driver has instructions to upload data fromdevice to web address automatically when device is attached); b) deviceloads unique patient ID into communication driver; c) device andcommunication driver both place unique patient ID in data stream; and d)central database recognizes and matches both unique patient IDs andstores data associated with this ID.

3) Shared Device in the Context where Patient May have Multiple AnalyteDevices.

This scenario expands on the case above. This scenario adds in the casewhere a patient uses a device that other patients may also use betweenupload operations (i.e., the analyte data in the device may come frommore than one patient with each upload cycle). This scenario could occurin a home setting for example where a device may be shared by severalpeople. In this case, it is necessary for the system to have positiveknowledge of the source of each analyte measurement. The flowchart inFIG. 4 provides a method in accordance with such an embodiment.

4) Patient Information Entered into the Device.

This scenario envisions the hospital setting where devices may be usedfor multiple patients sequentially, but not concurrently. Whenever a newpatient will be using a device, information identifying the patient canbe entered into the device and associated with the data when it is sentto the aggregating device. Patient data need only be entered once untilthe device is given to a new patient.

5) Shared Device with Self-Modifying Serial Number.

This scenario envisions a device given to a patient in a clinic in orderto take home. The device may not be as sophisticated as a hospitaldevice and therefore there may not be a way for the patient to enter anyidentifying information. Whenever the device is given to a new patient,a monotonically increasing identifier is added to the devices log. Thiscan be made to happen at the clinic by having a function built into thedevice for initializing a new patient. This function increments theidentifier and puts it in the log. Subsequently each record in the logis identified by the device's serial number, monotonically increasingidentifier, and record ID. The monotonically increasing identifier canbe said to be part of the device's serial number, so each time theaggregating database sees a new device serial number, it knows to ask ifthis is a new patient. It is assumed that the aggregating databasesoftware is running on a platform that can more easily handle userinput, such as a cell phone, tablet, or PC.

6) Lost or Stolen Device.

The analyte device may be lost or stolen. In order to guarantee dataintegrity, it is important that data entered by an unauthorized user notget assigned to the patient to whom the device was assigned, nor can theunauthorized user view the original patient's data. When theunauthorized user tries to upload the data to the central database, thedatabase will detect that the conduit (PC, cellphone, tablet, etc.) isdifferent than what was used by that patient before. The databasesoftware determines this because it has linked device ID, conduit, andpatient data in its database. The database software will issue apre-arranged challenge question to the user (e.g., What is your mother'smaiden name?). If the challenge is answered successfully, the databaseaccepts the data from the device, otherwise the data from that device isrejected and viewing of previous data is blocked. Furthermore, thesystem can be configured to only allow uploading when the device isconnected to a limited set of data conduits.

Another aspect of this invention provides for synchronization of databetween devices. For instance, if a patient utilized two differentdevices, it would be useful to have the data from one deviceadditionally stored on the other. As such, when the patient examinestheir data on one device, they may get a complete picture of theiranalyte measurements. Another example is a patient who has a device anda cellphone that accepts manual analyte reading entries (presumably froma separate device). The two devices could synchronize using wellestablished synchronization techniques (common with PDAs). They couldsynchronize periodically over a wireless channel such as Bluetooth. Theycould synchronize when connected via a wired channel. A preferred methodis that they could synchronize during upload of data to a centraldatabase. The central database would be aware of multiple devices ofcompatible data-types and would perform a difference of its stored data(after upload) from predefined period of time and download thedifference to the device to be stored. Variations of thissynchronization scheme can be contemplated.

Another aspect of this invention deals with the possibility thatidentical data may come through different conduits—such as a device thatcan upload both through a PC and through a cellular channel. To mitigate“double counting” of readings, additional data of a particular data-typewould be ignored (that is, not stored) by the central database if dataof that data-type already existed with the exact same timestamp.Alternatively, the data in this situation may be stored but flagged asduplicate. As such, data processing (or preprocessing) routines wouldneed to take the flagged duplicate data into account as needed.

Though this invention description may focus on blood glucose devices,the techniques described apply to all devices that may be used to uploadpatient analyte data or other patient data to a central database, suchas cell phones, tablet PC's, a dedicated communication router (e.g., viaBluetooth from the device and via cellular to the internet), etc., wherethe data may be aggregated with these devices from manual input, and/orwired or wireless communication from a measurement device or otherintermediate storage devices. This invention can also apply to anydevice used to measure patient data, such as continuous glucose (CG)devices, blood pressure (BP) measurement devices, height-scales, and thelike.

In another embodiment, there is provided mechanisms to enforce systemconfiguration requirements. Electronic system update configurationrequirements can be enforced using key codes that are incorporated inthe communication messages sent between system components. Key codes areprimarily available for access by a PC (or any other electronic device).The codes may be used as a convenient book keeping tool to manage whichversion of the device may function with a specific version of a PCapplication using a particular serial command. For instance, a serialcommand may include a two byte key code where in the original system thePC application will issue a value of code=00 when it sends the commandto a device. The original version of the device can be designed with aserial command function that will accept commands with code with a rangeof 00 to 0F. In this way, if another version of the device has anupdated serial command that allows a code range of 00 to 1F, then theoriginal PC application version will still work with this updateddevice, along with newer versions of the PC application that have codesin this range (in regards specifically to this particular serialcommand). If an updated PC application is not intended to work with thefirst device version but only the second device version, then the codefor the PC application should be set between 10 to 1F. If the updateddevice is not intended to work with the original PC application, thenthe code for the device could be set to 10 to 1F.

Another application for the key code mechanism has a key code includedin the pairing message exchange between the device and a drug deliverydevice, in the same fashion as described above for device serialcommands access primarily by PC applications. Here the unique feature isthat the key code only needs to be included in a pairing message inorder to enforce all communication restrictions between versions ofdevice and the drug delivery device, since they may not communicate(other than for pairing attempts) unless they are paired. This allowsfull control over which device versions will work with which drugdelivery device versions.

The same effect could be used by just changing the command name orformat. For instance, a device could be designed to accept serialcommands with names $acona, $aconb, and $aconx, and the PC applicationcould issue $aconb. Also, the device could be designed to accept aserial command with three parameters and with five parameters. However,the key code technique is much more convenient and easier to manage.

Integration with Medication Delivery Devices and/or Systems

In some embodiments, the analyte measurement systems disclosed hereinmay be included in and/or integrated with, a medication delivery deviceand/or system, e.g., an insulin pump module, such as an insulin pump orcontroller module thereof, or insulin injection pen. In some embodimentsthe analyte measurement system is physically integrated into amedication delivery device. In other embodiments, an analyte measurementsystem as described herein may be configured to communicate with amedication delivery device or another component of a medication deliverysystem. Additional information regarding medication delivery devicesand/or systems, such as, for example, integrated systems, is provided inU.S. Patent Application Publication No. US2006/0224141, published onOct. 5, 2006, entitled “Method and System for Providing IntegratedMedication Infusion and Analyte Monitoring System,” and U.S. PatentApplication Publication No. US2004/0254434, published on Dec. 16, 2004,entitled “Glucose Measuring Module and Insulin Pump Combination,” thedisclosure of each of which is incorporated by reference herein in itsentirety. Medication delivery devices which may be provided with analytemeasurement system as described herein include, e.g., a needle, syringe,pump, catheter, inhaler, transdermal patch, or combination thereof. Insome embodiments, the medication delivery device or system may be in theform of a drug delivery injection pen such as a pen-type injectiondevice incorporated within the housing of an analyte measurement system.Additional information is provided in U.S. Pat. Nos. 5,536,249 and5,925,021, the disclosures of each of which are incorporated byreference herein in their entirety.

The embodiments presented herein provide further advantages such as: theability to upgrade strip port modules as new test strip technologiesevolve; the ability to clean or sterilize a strip port module; and theability to allow users to replace strip port modules without returningthe entire measurement system to the manufacture.

Certain embodiments relate to in vivo (e.g., continuous monitoring)systems. A continuous monitoring system typically includes a sensor thatis worn or placed below the skin, a transmitter that collects glucoseinformation from the sensor, and a receiver that collects theinformation from the transmitter. The sensor can collect glucose levelinformation continuously, periodically, or at other intervals.Advantageously, a user is relieved from having to repeatedly lance hisor her body to collect a blood sample once the sensor is inserted,although the sensor (e.g., an electrochemical sensor that is insertedinto a body) can be replaced. U.S. Pat. No. 6,175,752, which is herebyincorporated by reference in its entirety, discloses additional examplesof a continuous monitoring system.

Embodiments of the invention relate to components of a continuousmonitoring system that may be replaceable. In one embodiment, theinterface between the sensor and the transmitter may becomecontaminated. The transmitter or sensor control unit, for example, mayhave an interface with the sensor that has been molded to form a barrierbetween the transmitter's contacts and circuitry internal to thetransmitter. This allows the transmitter's contacts to be washed withoutdamaging the transmitter's circuitry. Alternatively, the contacts may beincluded in a replaceable port that can be replaced as needed.Similarly, the interface on the sensor may be molded to form a barrierto contamination or be replaceable.

Embodiments of the invention further extend to kits. Examples of a kitinclude a measurement device with one or more strip connectors. In somekits, different strip connectors or ports for different types of stripsmay be included. This allows the measurement device to be used withdifferent strip form factors. The kits may also include a plurality oftest strips. In certain examples, the measurement device may beconfigured for use with disposable test strips as well as with teststrips that are configured for continuous monitoring systems. Thus, themeasurement device may include a receiver to receive information from atransmitter that collects glucose information from an inserted sensor.The measurement device may also include a strip connector, such as thosedisclosed herein, for use with single use test strips.

Analyte Test Strips

Analyte test strips for use with the present devices can be of any kind,size, or shape known to those skilled in the art; for example,FREESTYLE® and FREESTYLE LITE™ test strips, as well as PRECISION™ teststrips sold by ABBOTT DIABETES CARE Inc. In addition to the embodimentsspecifically disclosed herein, the devices of the present disclosure canbe configured to work with a wide variety of analyte test strips, e.g.,those disclosed in U.S. patent application Ser. No. 11/461,725, filedAug. 1, 2006, now U.S. Pat. No. 7,866,026; U.S. Patent ApplicationPublication No. 2007/0095661; U.S. Patent Application Publication No.2006/0091006; U.S. Patent Application Publication No. 2006/0025662; U.S.Patent Application Publication No. 2008/0267823; U.S. Patent ApplicationPublication No. 2007/0108048; U.S. Patent Application Publication No.2008/0102441; U.S. Patent Application Publication No. 2008/0066305; U.S.Patent Application Publication No. 2007/0199818; U.S. Patent ApplicationPublication No. 2008/0148873; U.S. Patent Application Publication No.2007/0068807; U.S. patent application Ser. No. 12/102,374, filed Apr.14, 2008, now U.S. Pat. No. 8,262,874, and U.S. Patent ApplicationPublication No. 2009/0095625; U.S. Pat. Nos. 6,616,819; 6,143,164;6,592,745; 6,071,391 and 6,893,545; the disclosures of each of which areincorporated by reference herein in their entirety.

Calculation of Medication Dosage

In one embodiment, the analyte measurement system may be configured tomeasure the blood glucose concentration of a patient and includeinstructions for a long-acting insulin dosage calculation function.Periodic injection or administration of long-acting insulin may be usedto maintain a baseline blood glucose concentration in a patient withType-1 or Type-2 diabetes. In one aspect, the long-acting medicationdosage calculation function may include an algorithm or routine based onthe current blood glucose concentration of a diabetic patient, tocompare the current measured blood glucose concentration value to apredetermined threshold or an individually tailored threshold asdetermined by a doctor or other treating professional to determine theappropriate dosage level for maintaining the baseline glucose level. Inone embodiment, the long-acting insulin dosage calculation function maybe based upon LANTUS® insulin, available from Sanofi-Aventis, also knownas insulin glargine. LANTUS® is a long-acting insulin that has up to a24 hour duration of action. Further information on LANTUS® insulin isavailable at the website located by placing “www” immediately in frontof “.lantus.com”. Other types of long-acting insulin include Levemir®insulin available from NovoNordisk (further information is available atthe website located by placing “www” immediately in front of“.levemir-us.com”. Examples of such embodiments are described in U.S.Patent Application Publication No. 2010/01981142, the disclosure ofwhich is incorporated herein by reference in its entirety.

Strip Port Configured to Receive Test Strips for Different Analytes

In another embodiment, there is provided an analyte measurement systemfor multi-chemistry testing. The test strips are for chemical analysisof a sample, and are adapted for use in combination with a measuringdevice having a test port and capable of performing a multiplicity oftesting functionalities. Each type of test strip corresponds to at leastone of the testing functionalities, and at least some types of teststrips have indicators of the testing functionality on them. The testport is adapted for use in combination with a multiplicity of differenttypes of test strips and includes a sensor capable of specificallyinteracting with the indicator(s) on the test strips, thereby selectingat least one of the multiplicity of testing functionalitiescorresponding to the type of test strip. Such system would include astrip port that can be used to read a test strip for glucose and a teststrip for ketone bodies. Examples of such embodiment are provided inU.S. Pat. No. 6,773,671, which is incorporated herein by reference inits entirety.

Strip Port Configured to Receive Test Strips Having Different Dimensionsand/or Electrode Configurations

In some embodiments, an analyte measurement system as described hereinincludes a strip port configured to receive test strips having differentdimensions and/or electrode configurations, e.g., as described in theU.S. patent application Ser. No. 12/695,947 filed on Jan. 28, 2010, nowU.S. Pat. No. 8,828,330, and entitled “Universal Test Strip Port”, thedisclosure of which is incorporated by reference herein in its entirety.

Implanted Analyte Sensor

In some embodiments, an analyte measurement system as described hereinmay include an implanted or partially implanted analyte sensor, e.g., asystem including an implanted or partially implanted glucose sensor(e.g., a continuous glucose sensor). A system including an implanted orpartially implanted glucose sensor may include an analyte measurementsystem as described herein, which is configured to receive analyte datafrom the implanted or partially implanted glucose sensor either directlyor through an intermediate device, e.g., an RF-powered measurementcircuit coupled to an implanted or partially implanted analyte sensor.In some embodiments, where an analyte measurement system according tothe present disclosure is integrated with an implanted sensor, theanalyte measurement system does not include a strip port for receivingan analyte test strip. In one embodiment, the analyte measurement systemmay be used to calibrate the analyte monitoring system, e.g., using onepoint calibration or other calibration protocol. For additionalinformation, see U.S. Pat. No. 6,175,752, the disclosure of which isincorporated by reference herein in its entirety. In some embodiments,the analyte measurement system may be configured to communicate with theimplanted or partially implanted analyte sensor via Radio FrequencyIdentification (RFID) and provide for intermittent or periodicinterrogation of the implanted analyte sensor.

Exemplary analyte monitoring systems that may be utilized in connectionwith the disclosed analyte measurement system include those described inU.S. Pat. Nos. 7,041,468; 5,356,786; 6,175,752; 6,560,471; 5,262,035;6,881,551; 6,121,009; 7,167,818; 6,270,455; 6,161,095; 5,918,603;6,144,837; 5,601,435; 5,822,715; 5,899,855; 6,071,391; 6,120,676;6,143,164; 6,299,757; 6,338,790; 6,377,894; 6,600,997; 6,773,671;6,514,460; 6,592,745; 5,628,890; 5,820,551; 6,736,957; 4,545,382;4,711,245; 5,509,410; 6,540,891; 6,730,200; 6,764,581; 6,299,757;6,461,496; 6,503,381; 6,591,125; 6,616,819; 6,618,934; 6,676,816;6,749,740; 6,893,545; 6,942,518; 6,514,718; 5,264,014; 5,262,305;5,320,715; 5,593,852; 6,746,582; 6,284,478; 7,299,082; U.S. ProvisionalApplication No. 61/149,639, entitled “Compact On-Body PhysiologicalMonitoring Device and Methods Thereof”, U.S. patent application Ser. No.11/461,725, filed Aug. 1, 2006, now U.S. Pat. No. 7,866,026, entitled“Analyte Sensors and Methods”; U.S. patent application Ser. No.12/495,709, filed Jun. 30, 2009, now U.S. Patent Application PublicationNo. 2010/0326842, entitled “Extruded Electrode Structures and Methods ofUsing Same”; U.S. Patent Application Publication No. 2004/0186365; U.S.Patent Application Publication No. 2007/0095661; U.S. Patent ApplicationPublication No. 2006/0091006; U.S. Patent Application Publication No.2006/0025662; U.S. Patent Application Publication No. 2008/0267823; U.S.Patent Application Publication No. 2007/0108048; U.S. Patent ApplicationPublication No. 2008/0102441; U.S. Patent Application Publication No.2008/0066305; U.S. Patent Application Publication No. 2007/0199818; U.S.Patent Application Publication No. 2008/0148873; U.S. Patent ApplicationPublication No. 2007/0068807; US Patent Application Publication No.2010/0198034; and U.S. Provisional Application No. 61/149,639 titled“Compact On-Body Physiological Monitoring Device and Methods Thereof”,the disclosures of each of which are incorporated herein by reference intheir entirety.

Communication Interface

As discussed previously herein, an analyte measurement system accordingto the present disclosure can be configured to include a communicationinterface. In some embodiments, the communication interface includes areceiver and/or transmitter for communicating with a network and/oranother device, e.g., a medication delivery device and/or a patientmonitoring device, e.g., a continuous glucose monitoring device. In someembodiments, the communication interface is configured for communicationwith a health management system, such as the CoPilot™ system availablefrom Abbott Diabetes Care Inc., Alameda, Calif.

The communication interface can be configured for wired or wirelesscommunication, including, but not limited to, radio frequency (RF)communication (e.g., Radio-Frequency Identification (RFID), Zigbeecommunication protocols, WiFi, infrared, wireless Universal Serial Bus(USB), Ultra Wide Band (UWB), Bluetooth® communication protocols, andcellular communication, such as code division multiple access (CDMA) orGlobal System for Mobile communications (GSM).

In one embodiment, the communication interface is configured to includeone or more communication ports, e.g., physical ports or interfaces suchas a USB port, an RS-232 port, or any other suitable electricalconnection port to allow data communication between the analytemeasurement system and other external devices such as a computerterminal (for example, at a physician's office or in hospitalenvironment), an external medical device, such as an infusion device orincluding an insulin delivery device, or other devices that areconfigured for similar complementary data communication.

In one embodiment, the communication interface is configured forinfrared communication, Bluetooth® communication, or any other suitablewireless communication protocol to enable the analyte measurement systemto communicate with other devices such as infusion devices, analytemonitoring devices, computer terminals and/or networks, communicationenabled mobile telephones, personal digital assistants, or any othercommunication devices which the patient or user of the analytemeasurement system may use in conjunction therewith, in managing thetreatment of a health condition, such as diabetes.

In one embodiment, the communication interface is configured to providea connection for data transfer utilizing Internet Protocol (IP) througha cell phone network, Short Message Service (SMS), wireless connectionto a personal computer (PC) on a Local Area Network (LAN) which isconnected to the internet, or WiFi connection to the internet at a WiFihotspot.

In one embodiment, the analyte measurement system is configured towirelessly communicate with a server device via the communicationinterface, e.g., using a common standard such as 802.11 or Bluetooth® RFprotocol, or an IrDA infrared protocol. The server device could beanother portable device, such as a smart phone, Personal DigitalAssistant (PDA) or notebook computer; or a larger device such as adesktop computer, appliance, etc. In some embodiments, the server devicehas a display, such as a liquid crystal display (LCD), as well as aninput device, such as buttons, a keyboard, mouse or touch-screen. Withsuch an arrangement, the user can control the analyte measurement systemindirectly by interacting with the user interface(s) of the serverdevice, which in turn interacts with the analyte measurement systemacross a wireless link.

In some embodiments, the communication interface is configured toautomatically or semi-automatically communicate data stored in theanalyte measurement system, e.g., in an optional data storage unit, witha network or server device using one or more of the communicationprotocols and/or mechanisms described above.

Input Unit

As discussed previously herein, an analyte measurement system accordingto the present disclosure can be configured to include an input unitand/or input buttons coupled to the housing of the analyte measurementsystem and in communication with a controller unit and/or processor. Insome embodiments, the input unit includes one or more input buttonsand/or keys, wherein each input button and/or key is designated for aspecific task. Alternatively, or in addition, the input unit may includeone or more input buttons and/or keys that can be ‘soft buttons’ or‘soft keys’. In the case where one or more of the input buttons and/orkeys are ‘soft buttons’ or ‘soft keys’, these buttons and/or keys may beused for a variety of functions. The variety of functions may bedetermined based on the current mode of the analyte measurement system,and may be distinguishable to a user by the use of button instructionsshown on an optional display unit of the analyte measurement system. Yetanother input method may be a touch-sensitive display unit, as describedin greater detail below.

In addition, in some embodiments, the input unit is configured such thata user can operate the input unit to adjust time and/or dateinformation, as well as other features or settings associated with theoperation of an analyte measurement system.

Display Unit

As discussed previously herein, in some embodiments, an analytemeasurement system according to the present disclosure includes anoptional display unit or a port for coupling an optional display unit tothe analyte measurement system. The display unit is in communicationwith a control unit and/or processor and displays the analyte test stripsignals and/or results determined from the analyte test strip signalsincluding, for example, analyte concentration, rate of change of analyteconcentration, and/or the exceeding of a threshold analyte concentration(indicating, for example, hypo- or hyperglycemia).

The display unit can be a dot-matrix display, e.g., a dot-matrix LCDdisplay. In some embodiments, the display unit includes a liquid-crystaldisplay (LCD), thin film transistor liquid crystal display (TFT-LCD),plasma display, light-emitting diode (LED) display, seven-segmentdisplay, E-ink (electronic paper) display or combination of two or moreof the above. The display unit can be configured to provide, analphanumeric display, a graphical display, a video display, an audiodisplay, a vibratory output, or combinations thereof. The display can bea color display. In some embodiments, the display is a backlit display.

The display unit can also be configured to provide, for example,information related to a patient's current analyte concentration as wellas predictive analyte concentrations, such as trending information.

In some embodiments an input unit and a display unit are integrated intoa single unit, for example, the display unit can be configured as atouch sensitive display, e.g., a touch-screen display, where the usermay enter information or commands via the display area using, forexample, the user's finger, a stylus or any other suitable implement,and where, the touch sensitive display is configured as the userinterface in an icon driven environment, for example.

In some embodiments, the display unit does not include a screen designedto display results visually. Instead, in some embodiments the optionaldisplay unit is configured to communicate results audibly to a user ofthe analyte measurement system, e.g., via an integrated speaker, or viaseparate speakers through a headphone jack or Bluetooth® headset.

Expanding Menu Item for Improved Readability

In some embodiments, the display unit includes a graphical userinterface including a plurality of menu items, wherein the display unitis configured to provide clarification with respect to the meaning of amenu item based on a user's response speed with respect to a user inputfor the menu item. The menu item could take any of a variety of forms,e.g., text, icon, object or combination thereof.

In one embodiment, the graphical user interface includes a menu which inturn includes a plurality of selectable menu items. As a user navigatesthrough the menu, e.g., by highlighting or scrolling through individualmenu items, a menu item that is either unreadable or incomprehensible tothe user could cause the user to pause over a menu item to be selected.In one embodiment, a choice can be presented to the user, e.g., using adedicated physical button on an input unit, or a soft key on the menu,that offers further explanation of the item to be selected withoutactually selecting the item. For example, the graphical user interfacecan be configured such that after a pre-determined period of time a softkey offers an explanation of the menu item to be selected, e.g., bydisplaying a soft key with the word “MORE”, “ADDITIONAL INFORMATION”,“EXPAND”, “MAGNIFY”, “HELP” or a variation thereof displayed thereon.

The pre-determined period of time may be based on a fixed factory presetvalue, a value set by the user or a health care provider, or through anadaptive mechanism based on an analysis of the user's speed ofnavigation from past interactions with the graphical user interface. Inone embodiment, the pre-determined period of time is from about 5 toabout 20 seconds, e.g., from about 10 to about 15 seconds.

If the offer for clarification and/or additional information isselected, e.g., by pressing the softkey, then the menu item to beselected can be displayed in a “high emphasis” mode, e.g., where theitem is displayed as if a magnifying lens is held on top of the selecteditem. In some embodiments, additional emphasis of the menu item to beselected can be provided, e.g., by making the menu item change color,blink, or increase in size to a pre-determined maximum limit.

Support for On-Demand Analyte Determination Using an Analyte Sensor

In some embodiments, an analyte measurement system according to thepresent disclosure is further configured to receive analyteconcentration data and/or signals indicative of an analyte concentrationfrom an analyte sensor, e.g., an implanted or partially implantedanalyte sensor or a radio-frequency (RF)-powered measurement circuitcoupled to an implanted or partially implanted analyte sensor. In someembodiments, the analyte sensor is a self-powered analyte sensor. Ananalyte measurement system according to the present disclosure mayinclude software configured to analyze signals received from the analytesensor. Additional information related to self-powered analyte sensorsand methods of communicating therewith are provided in U.S. PatentApplication Publication No. 2010/0213057, the disclosure of which isincorporated by reference herein in its entirety.

Analytes

A variety of analytes can be detected and quantified using the disclosedanalyte measurement system. Analytes that may be determined include, forexample, acetyl choline, amylase, bilirubin, cholesterol, chorionicgonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA,fructosamine, glucose, glutamine, growth hormones, hormones, ketones(e.g., ketone bodies), lactate, oxygen, peroxide, prostate-specificantigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.The concentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs ofabuse, theophylline, and warfarin, may also be determined. Assayssuitable for determining the concentration of DNA and/or RNA aredisclosed in U.S. Pat. Nos. 6,281,006 and 6,638,716, the disclosures ofeach of which are incorporated by reference herein in their entirety.

CONCLUSION

The foregoing description of the invention has been presented forpurposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise form disclosed.Other modifications and variations may be possible in light of the aboveteachings. The embodiments were chosen and described in order to bestexplain the principles of the invention and its practical application,and to thereby enable others skilled in the art to best utilize theinvention in various embodiments and various modifications as are suitedto the particular use contemplated. It is intended that the appendedclaims be construed to include other alternative embodiments of theinvention; including equivalent structures, components, methods, andmeans.

It is to be appreciated that the Detailed Description section, and notthe Summary and Abstract sections, is intended to be used to interpretthe claims. The Summary and Abstract sections may set forth one or more,but not all exemplary embodiments of the present invention ascontemplated by the inventor(s), and thus, are not intended to limit thepresent invention and the appended claims in any way.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the invention. The upper and lower limits of these smaller rangesmay independently be included or excluded in the range, and each rangewhere either, neither or both limits are included in the smaller rangesis also encompassed within the invention, subject to any specificallyexcluded limit in the stated range. Where the stated range includes oneor both of the limits, ranges excluding either or both of those includedlimits are also included in the invention.

In the description of the invention herein, it will be understood that aword appearing in the singular encompasses its plural counterpart, and aword appearing in the plural encompasses its singular counterpart,unless implicitly or explicitly understood or stated otherwise. Merelyby way of example, reference to “an” or “the” “analyte” encompasses asingle analyte, as well as a combination and/or mixture of two or moredifferent analytes, reference to “a” or “the” “concentration value”encompasses a single concentration value, as well as two or moreconcentration values, and the like, unless implicitly or explicitlyunderstood or stated otherwise. Further, it will be understood that forany given component described herein, any of the possible candidates oralternatives listed for that component, may generally be usedindividually or in combination with one another, unless implicitly orexplicitly understood or stated otherwise. Additionally, it will beunderstood that any list of such candidates or alternatives, is merelyillustrative, not limiting, unless implicitly or explicitly understoodor stated otherwise.

Various terms are described to facilitate an understanding of theinvention. It will be understood that a corresponding description ofthese various terms applies to corresponding linguistic or grammaticalvariations or forms of these various terms. It will also be understoodthat the invention is not limited to the terminology used herein, or thedescriptions thereof, for the description of particular embodiments.Merely by way of example, the invention is not limited to particularanalytes, bodily or tissue fluids, blood or capillary blood, or sensorconstructs or usages, unless implicitly or explicitly understood orstated otherwise, as such may vary.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the application. Nothing hereinis to be construed as an admission that the embodiments of the inventionare not entitled to antedate such publication by virtue of priorinvention. Further, the dates of publication provided may be differentfrom the actual publication dates which may need to be independentlyconfirmed.

The detailed description of the figures refers to the accompanyingdrawings that illustrate an exemplary embodiment of an analytemeasurement system. Other embodiments are possible. Modifications may bemade to the embodiment described herein without departing from thespirit and scope of the present invention. Therefore, the followingdetailed description is not meant to be limiting.

Certain embodiments presented herein relate to electrical interfaces inmeasurement devices. Measurement devices often have electricalinterfaces that allow them to electrically connect with another deviceor apparatus and perform an analysis of an analyte. A device thatmeasures blood glucose levels, for example, includes electricalinterfaces that allow the device to measure the blood glucose level froma small blood sample.

What is claimed is:
 1. A diabetes management system, comprising: aplurality of analyte measurement devices; and a centralized serverconfigured for data communication with the plurality of analytemeasurement devices; wherein each of the plurality of analytemeasurement devices comprises: a diabetes management softwareapplication; and one or more processors coupled to a memory, the memorybeing configured to store instructions that, when executed by the one ormore processors, cause the one or more processors to transmit one ormore communications to the centralized server, the one or morecommunications comprising: a version number associated with the diabetesmanagement software application, a unique patient ID associated with auser of the analyte measurement device, data indicative of measuredanalyte levels associated with the user of the analyte measurementdevice, and one or more timestamps associated with the data indicativeof measured analyte levels, and wherein the centralized server includesat least one computer readable medium having instructions executable byat least one processing device that, when executed, cause the at leastone processing device to: store the unique patient ID received from eachof the plurality of analyte measurement devices in a database, andaggregate, based on the stored unique patient ID, the data indicative ofmeasured analyte levels from each of the plurality of analytemeasurement devices.
 2. The system of claim 1, wherein at least one ofthe plurality of analyte measurement devices includes a communicationmodule adapted for wireless communication with the centralized server.3. The system of claim 2, wherein the communication module is configuredto wirelessly communicate with the centralized server according to a802.11 communication protocol.
 4. The system of claim 2, wherein thecommunication module is configured to communicate with the centralizedserver according to a cellular communication protocol.
 5. The system ofclaim 2, wherein at least one of the plurality of analyte measurementdevices comprises a smartphone.
 6. The system of claim 1, wherein theinstructions of the at least one computer readable medium of thecentralized server, when executed by the at least one processing device,further cause the at least one processing device to aggregate the dataindicative of measured analyte levels from each of the plurality ofanalyte measurement devices based, at least in part, on a key codeassociated with the diabetes management software application.
 7. Thesystem of claim 1, wherein the instructions of the at least one computerreadable medium of the centralized server, when executed by the at leastone processing device, further cause the at least one processing deviceto provide an indication that the version number of the diabetesmanagement software application is valid, and wherein the version numberof the diabetes management software application is indicative of eachspecific version of an application installed on each analyte measurementdevice of the plurality of analyte measurement devices.
 8. The system ofclaim 1, wherein at least one of the analyte measurement devices isconfigured to measure a blood glucose level of a patient.
 9. The systemof claim 1, wherein at least one of the plurality of analyte measurementdevices is configured to communicate analyte measurement data to thecentralized server using a wired connection.
 10. The system of claim 9,wherein the wired connection is a USB connection to a personal computer,wherein the personal computer is configured for data communication withthe centralized server.
 11. The system of claim 1, further comprising aplurality of transmitters, each of which is operatively coupled with acorresponding sensor, wherein each corresponding sensor comprises aportion that is placed below a user's skin and configured to sense ananalyte level, wherein each transmitter is configured to collect signalsindicative of the analyte level from the corresponding sensor, andwherein the plurality of analyte measurement devices is configured tocollect analyte level information from the plurality of transmitters.12. The system of claim 11, wherein each of the plurality of analytemeasurement devices is configured to communicate with a correspondingtransmitter of the plurality of transmitters according to a Bluetoothcommunication protocol.
 13. An analyte monitoring system, comprising:(1) an on-body unit comprising: a sensor, at least a portion of which isplaced below a user's skin and configured to sense glucose levels of theuser, and a communication module operatively coupled to the sensor andconfigured to transmit data indicative of the glucose levels; and (2) ahand-held receiver comprising: one or more communication modulesconfigured for: wireless communication with the on-body unit and toreceive the data indicative of the glucose levels, and datacommunication with a centralized server, a diabetes management softwareapplication, and one or more processors coupled to a memory, the memorybeing configured to store instructions that, when executed by the one ormore processors, cause the one or more processors to transmit one ormore communications to the centralized server, the one or morecommunications comprising: a version number associated with the diabetesmanagement software application; a unique patient ID associated with theuser of the analyte monitoring system; the data indicative of theglucose levels; and one or more timestamps associated with the dataindicative of the glucose levels; and (3) the centralized serverconfigured for data communication with the hand-held receiver, whereinthe centralized server includes at least one computer readable mediumhaving instructions executable by at least one processing device that,when executed, cause the at least one processing device to: store theunique patient ID received from the hand-held receiver in a database,and aggregate, based on the stored unique patient ID, the dataindicative of the glucose levels from the hand-held receiver.
 14. Thesystem of claim 13, wherein the one or more communication modules of thehand-held receiver is configured to communicate with the communicationmodule of the on-body unit according to a Bluetooth communicationprotocol.
 15. The system of claim 14, wherein the one or morecommunication modules of the hand-held receiver is configured tocommunicate with the centralized server according to a 802.11communication protocol.
 16. The system of claim 14, wherein the one ormore communication modules of the hand-held receiver is configured tocommunicate with the centralized server according to a cellularcommunication protocol.
 17. The system of claim 14, wherein thehand-held receiver comprises a smartphone.
 18. The system of claim 13,wherein the data indicative of the glucose levels is aggregated by thecentralized server based, at least in part, on the key code associatedwith the diabetes management software application.
 19. The system ofclaim 13, wherein the hand-held receiver is configured to receive anindication of whether the diabetes management software is valid based,at least in part, on the version number associated with the diabetesmanagement software application, and wherein the version numberassociated with the diabetes management software application isindicative of a specific version of an application installed on thehand-held receiver.